Genetic Testing for the Prevention of Cancer in Indigenous American Communities (JUNIPER Trial)

Not Applicable

Recruiting

• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Interventions: Procedure: Biospecimen Collection; Other: Communication Intervention; Other: Genetic Testing; Other: Survey Administration

• Registration Number: NCT06569316
• Lead Sponsor: Mayo Clinic

Brief Summary

This clinical trial is studying the genetic changes in cells associated with different types of cancer in Indigenous American (IA) populations in the Southwest to improve cancer screening, precision prevention, and therapeutic intervention for individual in these communities. IA tribes have much lower rates of cancer screening, have more limited access to healthcare, are more often diagnosed at later stages of disease, and have the poorest outcomes in all types of cancer when compared to any other racial and ethnic group in the United States. Due to these significant cancer health disparities, IAs have been understudied and little is known about the molecular characterization of tumors arising in IAs. Undergoing genetic testing of tumors may improve cancer outcomes in IA participants and communities.

Detailed Description

PRIMARY OBJECTIVES:

I. To develop culturally appropriate, respectful, trusted, and collaborative means to engage and recruit Indigenous Americans (IAs) affected by cancer (newly diagnosed cancer participants, participants undergoing cancer treatment, and cancer survivors) for molecular characterization of their tumors.

Ia. Conduct direct participant engagement with cancer participants/survivors, community advisors, and partners to refine and optimize methods/processes.

Ib. Identify, recruit, and consent eligible IA cancer participants/survivors. Ic. Implement tissue acquisition, epidemiologic, behavioral, and clinical data collection, conduct continuous assessment of performance benchmarks.

Id. Return clinical grade and clinically useful genomic data to participants with navigation to counseling and clinical resources as warranted and as they select.

SECONDARY OBJECTIVE:

I. Translate any discoveries to improved cancer screening, precision prevention, and therapeutic intervention that can be used to enhance cancer screening and precision prevention and improve cancer outcomes in Indigenous American participants and communities.

OUTLINE:

Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from standard of care (SOC) surgical procedure or biopsy, or stored tissue samples for genetic testing on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.

After completion of study intervention, patients are followed up once a year up to 5 years from study registration.

Study Timeline

• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Study Start: 2024-09-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Male or female adults >= 18 years of age
• Cancer patient undergoing active treatment or a cancer survivor
• Self-identify as Indigenous American

Exclusion Criteria

• Unable to provide informed consent
• Individuals who are under 18 years of age
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening (blood, saliva, tissue collection, genetic testing)	Biospecimen Collection	Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from SOC surgical procedure or biopsy, or stored tissue samples for genetic testing on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
Screening (blood, saliva, tissue collection, genetic testing)	Survey Administration	Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from SOC surgical procedure or biopsy, or stored tissue samples for genetic testing on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
Screening (blood, saliva, tissue collection, genetic testing)	Communication Intervention	Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from SOC surgical procedure or biopsy, or stored tissue samples for genetic testing on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
Screening (blood, saliva, tissue collection, genetic testing)	Genetic Testing	Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from SOC surgical procedure or biopsy, or stored tissue samples for genetic testing on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.

Primary Outcome Measures

Name	Time	Method
Successful accrual of Indigenous American (IA) participants	Up to 5 years	Assessed by the number of IA participants consented to study.
Return of valuable genetic results to participants	Up to 5 years	Assessed by the number of participants who receive genetic results. Clinically useful genomic data will be returned to participants with navigation to counseling and clinical resources as warranted and as they select.

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States